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Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women

Pharmacokinetics of a Single Oral Dose of Maxmarvil® in Healthy Postmenopausal Women Without a Previous History of Fractures

NCT01526278•Yuyu Pharma, Inc.

View on ClinicalTrials.gov

Summary

This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women

Detailed Description

Pharmacokinetics of a single Oral Dose of Maxmarvil® in healthy postmenopausal women without a previous history of fractures 1. evaluation of Pharmacokinetics * Urine collection : Pre-dose(pre 1hour), post-dose 0\~6 hour, 6\~12 hour, 12\~24 hour * Evaluation Variables : Aet 2. Evaluation of safety, pharmacodynamics * Adverse Event : check it every and frequently * Physical exam : screening, just before injection, post-dose 24 hour and post-study visit * Vital sign : screening, just before injection, post-dose 1 hour, 24 hour and post-study visit * Laboratory test : screening, post-dose 24hour

Eligibility

Age

55 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Screening test in healthy postmenopausal women without a previous history of fracture
•Normal range in laboratory test arranged by principal investigator because of the character of medicine
•over 50kg, body weight is in ± 20% of ideal body weight Written concent by himself and following the protocol after understanding of the explained clinical trial

Exclusion Criteria

•Subject who have taken something to induce and inhibit the drug metabolizing enzyme within 1 month like Barbiturate.
•Subject who have a history of drug abuse and got a positive in urine test for drug abuse.
•Subject who have taken a prescription only medicine or an oriental medicine within 2 weeks after first administration the clinical drug trial , taken a OTC within 1 week after first administration the clinical drug trial like some OTC including calcium, an antacids, multiple vitamin, mineral.
•Subject who have been chronic drinking(over 21 units/week) or can not stop drinking during the clinical trial.
•Subject who have smoked over 10 unit/day for 3months.
•Subject who have light or clear hypersensitivity reaction about OTC(aspirin, antibiotic medication) or bisphosphonates(alendronate)
•Subject who have got a disease about liver, kidney, neurology, respiratory, endocrine, hematooncology, cardiovascular, musculoskeletal, psychological or history of fracture within 12months or a tooth extraction within 6month
•Subject who have a history of gastrointestinal disease or stomach surgery without appendectomy, herniotomy having an effort the absorb of clinical drug trial.
•Subject who have a esophageal disease like esophagitis, esophageal ulcer, esophagus erosion, esophagorrhaphy, esophagostenosis, dysphagia.
•Subject who can not keep the sitting position for 30minutes
+6 more criteria

Locations (1)

Ajou University Hospital

Suwon, South Korea

Key Dates

Start Date

October 1, 2011

Primary Completion Date

July 1, 2012

Completion Date

September 1, 2012

Last Updated

February 25, 2019

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

Maxmarvil®

DRUG

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

NCT07281586

Osteoporosis

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RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

Smart Wearable Device (gaitQ): Walk Better Project

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